Detection of PCOS by Sensors Array
February 12, 2017 updated by: Meir Medical Center
Detection of PCOS and Ovulation Timing by NA-Nose
Detection of metabolic state of women with polycystic ovary using NA-Nose.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Breath of women undergoing fertility treatment including PCOS and ovulatory women will be collected and transferred for our labs for further analysis in define the metabolic state.
The detection will be made using sensors arrays and GCMS.
Study Type
Interventional
Enrollment (Anticipated)
200
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:women undergoing follow up for ovulation detection. -
Exclusion Criteria:Pregnancy
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: ovulatory
Comparison in metabolic state between ovulatory and PCOS women by collecting breath test from participant.
|
Collecting breath test from participants
|
|
Active Comparator: PCOS
Comparison in metabolic state between ovulatory and PCOS women by collecting breath test from participant
|
Collecting breath test from participants
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Detection of different metabolic state between groups.
Time Frame: two years
|
Finding that there special markers in the breath test that indicate a different metabolic state in PCOS.
|
two years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
March 1, 2017
Primary Completion (Anticipated)
January 1, 2019
Study Completion (Anticipated)
March 1, 2019
Study Registration Dates
First Submitted
February 6, 2017
First Submitted That Met QC Criteria
February 6, 2017
First Posted (Estimate)
February 8, 2017
Study Record Updates
Last Update Posted (Actual)
February 14, 2017
Last Update Submitted That Met QC Criteria
February 12, 2017
Last Verified
February 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- 020916COM1k
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.